Tirofiban vs standard antiplatelet therapy in acute branch atheromatous disease-related stroke: a multicenter, randomized, open-label, blinded-endpoint, parallel-group, phase III clinical trial
In brief
Tirofiban did not improve 90-day outcomes; excellent function stayed near 70%
In a randomized trial of 513 patients with branch atheromatous disease-related stroke, about 70% in each group achieved excellent function at 90 days with tirofiban or standard antiplatelet therapy. Major bleeding was rare in both groups. The result applies to tirofiban started within 48 hours without oral antiplatelets; earlier treatment and other treatment combinations remain untested.
- Journal
- The Lancet regional health. Western Pacific (Q1)
- Published
- 7 October 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Shengde Li, Haizhou Hu, Dingding Zhang, Bin Liu, Mengfei Zhong, Lihua Wang, et al.
- PMID
- 42894564
- DOI
- 10.1016/j.lanwpc.2026.101995
Why clinicians should know about it
- Picked for Internal Medicine (paper of the day, 21 October 2026): Phase III RCT tirofiban vs standard antiplatelet in stroke
Abstract
BACKGROUND: Tirofiban is sometimes used empirically for branch atheromatous disease (BAD)-related stroke, but its benefit in this population remains unclear. This study aimed to assess the efficacy and safety of intravenous tirofiban administered within 48 h of onset in patients with acute BAD-related stroke. METHODS: This multicentre, randomized, open-label, blinded-endpoint clinical trial enrolled patients with BAD-related stroke within 48 h of onset from 25 hospitals in China between 9 November 2023 and 22 November 2025. Eligible patients were randomly assigned to the tirofiban group (intravenously, 0.4 μg/kg per minute for 30 min, followed by a 0.1 μg/kg per minute for 47.5 h) or standard antiplatelet therapy group (oral aspirin with or without clopidogrel) for 48 h. The primary endpoint was an excellent functional outcome, defined as a score of 0 or 1 on the modified Rankin Scale at 90 days. Safety outcomes included major bleeding within 90 days. This trial was registered on ClinicalTrials.gov (NCT06037889). FINDINGS: Among 516 patients randomized, 513 were included in the primary analysis (258 with tirofiban and 255 with standard antiplatelet therapy). An excellent functional outcome was observed in 181 of 258 patients (70.2%) in the tirofiban group and 178 of 255 (69.8%) in the standard antiplatelet therapy group (risk ratio, 1.01 [95% CI, 0.90-1.13]; P = 0.93). Major bleeding occurred in 0 of 259 participants in the tirofiban-exposed safety population and 1 of 245 (0.4%) in the standard-antiplatelet-exposed safety population. INTERPRETATION: Among patients with acute BAD-related stroke, intravenous tirofiban administered within 48 h of onset without concomitant oral antiplatelet therapy was not superior to standard antiplatelet therapy for achieving an excellent functional outcome at 90 days. These findings should not be extrapolated to substantially earlier treatment or to other tirofiban-based antiplatelet strategies. FUNDING: National High Level Hospital Clinical Research Funding, Capital's Funds for Health Improvement and Research, CAMS Innovation Fund for Medical Sciences (CIFMS), Noncommunicable Chronic Diseases-National Science and Technology Major Project, and China Shijiazhuang Pharmaceutical Company (CSPC) NBP Pharmaceurical Co., Ltd.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.